COVID-19 Vaccines: Information Updates

See below for full prescribing information for all four vaccines currently available in Ireland.

Comirnaty COVID-19 Vaccine (Pfizer/BioNTech)

  • Safety Update (EMA 11 November 2021): There are no updates to the product information. Further assessment of myocarditis and pericarditis is ongoing. There is currently insufficient evidence of a possible link between Comirnaty and very rare cases of multisystem inflammatory syndrome (MIS).
  • Safety Update (EMA 06 October 2021): Erythema multiforme (red spots/patches on the skin) and unusual or decreased feeling in the skin will be added to the product information as side effects.
  • Safety Update (EMA 08 September 2021): No further updates to the product information are currently recommended.
  • Safety Update (EMA 11 August 2021): No further updates to the product information are currently recommended.
  • Safety Update (EMA 14 July 2021): Inflammation of the heart muscle (myocarditis) or membrane (pericarditis) may occur in a small number of people after vaccination with Comirnaty. The product information will be updated. Comirnaty is effective in preventing COVID-19.
  • Safety Update (EMA 18 June 2021): Reports of inflammation of the heart muscle (myocarditis) and membrane (pericarditis) in a small number of people after vaccination continue to be assessed under an accelerated timetable. There are no updates to the product information. Comirnaty is effective in preventing COVID-19. 
  • More Flexible Storage Conditions (EMA 17 May 2021): The EMA human medicines committee (CHMP) has recommended a change to the approved storage conditions that will facilitate the handling of the vaccine in vaccination centres across the European Union (EU). The changes described will be included in the publicly available information on and will be implemented by the MAH in updated product labelling. Users are reminded to always refer to the label and package leaflet of the supplied product for the correct storage information. This change extends the approved storage period of the unopened thawed vial at 2-8°C (i.e. in a normal fridge after taking out of deep-freeze conditions) from five days to one month (31 days). The change was approved following assessment of additional stability study data submitted to EMA by the marketing authorisation holder (MAH). Increased flexibility in the storage and handling of the vaccine is expected to have a significant impact on planning and logistics of the vaccine roll-out in EU Member States. 
  • Safety Update (EMA 11 May 2021): Swelling of the face in people who have had a dermal filler injection will be added to the product information of Comirnaty as a side effect. Case reports of inflammation of the heart muscle and membrane will be further assessed.
  • Adolescent Indication (EMA 02 May 2021): Indication extended to include adolescents from age 12 years.
  • Safety Update (EMA 14 April 2021): Specific allergic skin reactions will be added to the product information.
  • Safety Update (EMA 29 March 2021): Swelling of the vaccinated limb usually recovers by itself.
  • Safety Update (EMA 04 March 2021): Diarrhoea and vomiting after vaccination have been identified as new side effects.
  • Safety Update (EMA 28 January 2021): Reports of suspected severe allergic reaction have not identified new aspects regarding the nature of this known side effect. No specific safety concern has been identified for vaccine use in frail elderly individuals.

 Spikevax COVID-19 Vaccine (previously Moderna COVID-19 Vaccine) (Moderna)

  • Safety Update (EMA 11 November 2021): There are no updates to the product information. Further assessment of myocarditis and pericarditis is ongoing. There is currently insufficient evidence of a possible link between Spikevax and very rare cases of multisystem inflammatory syndrome (MIS).
  • Safety Update (EMA 06 October 2021): Erythema multiforme (red spots/patches on the skin) will be added to the product information as a side effect.
  • Safety Update (EMA 08 September 2021): No further updates to the product information are currently recommended.
  • Safety Update (EMA 11 August 2021): No further updates to the product information are currently recommended.
  • Safety Update (EMA 14 July 2021): Inflammation of the heart muscle (myocarditis) or membrane (pericarditis) may occur in a small number of people after vaccination with Spikevax. The product information will be updated. Spikevax is effective in preventing COVID-19.
  • Safety Update (EMA 18 June 2021): Reports of inflammation of the heart muscle (myocarditis) and membrane (pericarditis) in a small number of people after vaccination continue to be assessed under an accelerated timetable. There are no updates to the product information. Spikevax (previously Moderna COVID-19 Vaccine) is effective in preventing COVID-19.
  • Safety Update (EMA 11 May 2021): Diarrhoea and delayed injection site reactions will be added as side effects to the product information. Case reports of inflammation of the heart muscle and membrane will be further assessed.
  • Safety Update (EMA 05 February 2021): This update presents the assessment of an investigation of reports of suspected severe allergic reaction coming from a single vaccination site in the United States. The assessment of these reports has not identified new aspects regarding the nature of this known side effect.

COVID-19 Vaccine Janssen (Janssen-Cilag/Johnson & Johnson)

  • Safety Update (EMA 11 November 2021): There are no updates to the product information. There is currently insufficient evidence of a possible link between COVID-19 Vaccine Janssen and either multisystem inflammatory syndrome (MIS) or menstrual disorders.
  • Safety Update (EMA 06 October 2021): Venous thromboembolism (VTE) (blood clotting in the veins) and immune thrombocytopenia (ITP), (and autoimmune condition with low blood blood platelet levels) will be added to the product information as side effects, together with warnings and advice.
    Transverse myelitis (inflammation in parts of the spinal cord) was recommended by the EMA Pharmacovigilance Risk Assessment Committee (PRAC) to be added to the product information as a side effect of COVID-19 Vaccine Janssen.
  • Safety Update (EMA 08 September 2021): Recommended product information update to include swollen lymph nodes, unusual or decreased feeling in the skin, tinnitus, diarrhoea and vomiting as side effects.
  • Safety Update (EMA 11 August 2021): Guillain-Barré syndrome has been added to the product information as a very rare side effect. Recommended to update the product information to include immune thrombocytopenia, dizziness and tinnitus as side effects. 
  • Safety Update (EMA 14 July 2021): People who have previously had capillary leak syndrome must not receive COVID-19 Vaccine Janssen. Capillary leak syndrome may also occur as a side effect of COVID-19 Vaccine Janssen. The product information will be updated. COVID-19 Vaccine Janssen is effective in preventing COVID-19.
  • Safety Update (EMA 18 June 2021): There are no updates to the product information. COVID-19 Vaccine Janssen is effective in preventing COVID-19.
  • Safety Update (EMA 11 May 2021): Individuals diagnosed with thrombocytopenia within 3 weeks after vaccination with COVID-19 Vaccine Janssen should be actively investigated for signs of thrombosis; similarly, individuals who present with thrombosis within 3 weeks of vaccination should be evaluated for thrombocytopenia
  • Safety Update (EMA 27 April 2021): Unusual blood clots in combination with low blood platelet levels have been identified as a very rare side effect of COVID-19 Vaccine Janssen. Vaccinated persons should seek immediate medical attention if symptoms of blood clotting occur, to help avoid complications.

Vaxzevria COVID-19 Vaccine (AstraZeneca)

  • Safety Update (EMA 11 November 2021): Cerebrovascular venous and sinus thrombosis (CVST; blood clots in the brain) without thrombocytopenia (low blood platelet levels) has been observed very rarely following vaccination with Vaxzevria. CVST will be added to the product information as a side effect of Vaxzevria.
  • Safety Update (EMA 06 October 2021): Immune thrombocytopenia (an autoimmune condition with low blood platelet levels) will be added to the product information as a side effect, together with a warning and advice about thrombocytopenic disorders.
  • Safety Update (EMA 08 August 2021): The product information will be updated with Guillain-Barré syndrome (GBS) as a side effect of Vaxzevria. Pain in legs and arms or stomach and influenza-like symptoms have also been included in the product information as side effects. 
  • Safety Update (EMA 11 August 2021): No further updates to the product information are currently recommended.
  • Safety Update (EMA 14 July 2021): Vaccinated persons need to seek immediate medical attention if they develop weakness and paralysis in the extremities, possibly progressing to the chest and face, after vaccination with Vaxzevria, as these could be signs of Guillain-Barré syndrome. The product information will be updated. Vaxzevria is effective in preventing COVID-19.
  • Safety Update (EMA 18 June 2021): People who have previously had capillary leak syndrome must not receive Vaxzevria. Capillary leak syndrome may also occur as a side effect of Vaxzevria. The product information will be updated. Vaxzevria is effective in preventing COVID-19.
  • Safety Update (EMA 21 May 2021): Individuals who previously had blood clots with low blood platelets (thrombosis with thrombocytopenia syndrome, TTS) after Vaxzevria must not be given a second dose of Vaxzevria. Individuals with low blood platelets within 3 weeks after vaccination with Vaxzevria should be actively investigated for signs of blood clots; similarly, individuals who present with blood clots within 3 weeks of vaccination should be evaluated for low blood platelets. Patients who have blood clots with low blood platelets after vaccination require specialist medical care. Hypersensitivity reactions presenting as hives or rapid swelling under the skin in areas such as the face, lips, mouth and throat are newly identified side effects of Vaxzevria.
  • Safety Update (EMA 11 May 2021): Individuals diagnosed with thrombocytopenia within 3 weeks after vaccination with Vaxzevria should be actively investigated for signs of thrombosis; similarly, individuals who present with thrombosis within 3 weeks of vaccination should be evaluated for thrombocytopenia.
  • Safety Update (EMA 14 April 2021): Very rare, potentially serious, events of unusual blood clots in combination with low blood platelet levels have been confirmed as a new side effect of Vaxzevria.
  • Safety Update (EMA 29 March 2021): Severe allergic reaction will be included in the product information as a known side effect. A warning on very rare specific blood clot events has been included in the product information, while further investigations into a possible causal relationship with the vaccine are ongoing. Vaccinated persons should seek immediate medical attention if symptoms of blood clotting and/or bleeding occur.

COVID-19 Vaccines: Prescribing Information

Class Effects for mRNA and rDNA Vaccines

Class information is based on the four vaccines currently being used in Ireland.
In order to improve traceability of biological medicinals, clearly record the name and the batch number of the administered product.
 
CI: Hypersensitivity to any member of the class, vaccine component, trace substances after manufacture or following previous admin of a similar vaccine. Use of live viruses with immunosuppression (chemo- or radiotherapy, organ or bone marrow transplantation and/or currently on immunosuppressives including corticosteroids); impaired cell-mediated immunity (HIV infection, Severe Combined Immunodeficiency Syndrome, Di George Syndrome or congenital/hereditary immunodeficiency; severe humoral or cellular, primary or acquired immunodeficiency).
 
Interaction(s): Effect of Other Drugs on COVID-19 mRNA or rDNA Vaccines: No interaction studies performed.
 
SP: Hypersensitivity and anaphylaxis. Appropriate medical treatment and supervision to be available in case of anaphylactic reaction. Close observation for minimum 15 minutes after vaccination. 
Anxiety-related reactions e.g. vasovagal reactions (syncope), hyperventilation or stress-related reactions (dizziness, palpitations, increased heart rate, altered blood pressure, tingling sensations, sweating) may occur in association with the vaccination process itself. Usually temporary and resolve on their own. Advise vaccinees to bring symptoms to attention of vaccination provided to evaluate. Ensure precautions to avoid injury from fainting.
Concurrent illness, postpone (acute severe febrile illness, acute infection); do not delay (minor infection, low-grade fever). 
Thrombocytopenia, any coagulation disorder, individuals receiving anticoagulants, weigh risk/benefit of using IM route (bleeding or bruising may occur following IM admin). Vaccines may not protect 100% of recipients; reduced immunogenicity in immuno-compromised (immunosuppressive therapy, genetic causes). Duration of protection is still being determined by ongoing clinical trials.
 
Fertility, Pregnancy, Lactation: Pregnancy, limited experience. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development. Use in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.
Breast-feeding, unknown if excreted in human milk.
Fertility, animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity
 
Driving: Possible side-effects may affect ability. Do not drive if feeling unwell after vaccination.

COVID-19 mRNA Vaccines

  • ATC Code: J07BX03. 
  • Indication(s): Prevention, COVID-19 disease caused by SARS-CoV-2 virus from age 12 years (Comirnaty), from age 18 years (Spikevax). 
  • Dose: Adult: Comirnaty, from age 12 years, after dilution, as a 2-dose course (0.3mL each). Recommend to administer second dose 3 weeks after first dose. Spikevax, from age 18 years, as a 2-dose course (0.5mL each) 28 days apart. Interchangeability with other COVID-19 vaccines to complete vaccination course, no data. Recommend course is completed with same vaccine as initial dose. Admin, IM injection, preferably deltoid muscle of upper arm. NOT for IV, SC or intradermal injection.
  • Elderly: No dose adjustment.
  • Child: Age 12 years (Comirnaty) or 18 years (Spikevax) and older, as for Adult. Under 12 years (Comirnaty) or under 18 years (Spikevax), safety and efficacy not established.
  • SP: Anaphylaxis with first dose, do not administer second dose. Individuals vaccinated may not be fully protected until 7 days (Comirnaty) or 14 days (Spikevax) after the second dose. Myocarditis and pericarditis (rare); primarily occurred with 14 days post-vaccination; more often after second vaccine and in younger men. Ensure vaccinees understand to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis e.g. (acute and persisting) chest pain, shortness of breath, palpitations (after vaccination). Erythema multiforme (red spots/patches on the skin) and unusual or decreased feeling in the skin. Anxiety-related reactions, concurrent illness, thrombocytopenia, coagulation disorders, see Class Effects above. 
  • ADR: Summary, most frequent: Both brands, injection site pain, fatigue, headache, myalgia, chills, arthralgia, pyrexia, injection site swelling. Adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. A slightly lower frequency of reactogenicity events was associated with greater age. Comirnaty, safety profile in adolescents aged 12-15 years was similar to age 16 years and older; most frequent, fatigue, headache, myalgia, chills, arthralgias, pyrexia. Spikevax, (additional), nausea and vomiting, axillary swelling and/or tenderness, fever, injection site redness. Overall, higher incidence of some adverse reactions in younger age groups e.g. axillary swelling or tenderness, fatigue, headache, myalgia, arthralgia, chills, nausea and/or vomiting and fever was higher in ages 18 to under 65 years than in age 65 years and older. Local and systemic reactions were more frequently reported after Dose 2 than after Dose 1.
Comirnaty COVID-19 Vaccine (Pfizer/BioNTech)          
Injection, COVID-19 mRNA 30mcg/0.3mL dose embedded in lipid nanoparticles. Single-stranded mRNA (in vitro transcription) encoding SARS-CoV-2 viral spike (S) protein. White (off-white) frozen dispersion (concentrate). 
Excipient(s): Essentially sodium- and potassium-free. 
Store: Unopened vial, frozen: Six months frozen at -90 to -60 deg C. Original pack (light). Can be stored and transported at -25 to -15 deg C for single 2-week period then can be returned to -90 to -60 deg C. Unopened vial, thawed: One month at 2-8 degrees C. Within this 1-month, up to 12 hours may be used for transportation. Before using, up to 2 hours at temperatures of up to 30 deg C. Do not refreeze thawed vial. Thawed vial can be handled in room light conditions.
[Information up-to-date (EMA): October 2021]
 
▼ Spikevax COVID-19 Vaccine (formerly Moderna COVID-19 Vaccine) (Moderna)
Injection, COVID-19 mRNA 100mcg/0.5mL dose embedded in lipid nanoparticles. Single-stranded mRNA (in vitro transcription) encoding SARS-CoV-2 viral spike (S) protein. White (off-white) dispersion. 
Excipient(s): Essentially sodium-free. 
Store: Freeze at -25 to -15 deg C. Original pack (light). Do not store on dry ice or below -40 deg C. Thawed vaccine, up to 30 days at 2-8 degrees C; do not refreeze. Removed from refrigerator, up to 12 hours at 8-25 deg C.
[Information up-to-date (EMA): October 2021]

COVID-19 rDNA Vaccines

  • ATC Code: J07BX03. 
  • Indication(s): Prevention, COVID-19 disease caused by SARS-CoV-2 virus from age 18 years. 
  • Dose: Adult: From age 18 years: Janssen, as a single dose (0.5mL). Vaxzevria, as a 2-dose course (0.5mL each) between 4 and 12 weeks (28-84 days) apart. Interchangeability with other COVID-19 vaccines to complete vaccination course, no data. Recommend course is completed with same vaccine as initial dose. Admin, IM injection ONLY, preferably deltoid muscle of upper arm. NOT for IV, SC or intradermal injection.
  • Elderly: No dose adjustment.
  • Child: Age 18 years and older, as for Adult. Under 18 years, safety and efficacy not established.
  • CI: Individuals who have experienced thrombosis with thrombocytopenia syndrome (TTS) following vaccination with Vaxzevria. Individuals who have previously experienced episodes of capillary leak syndrome (CLS) (Janssen).
  • SP: Anaphylaxis with first dose, do not administer second dose. Individuals vaccinated may not be fully protected until 14 days after vaccination (Janssen) OR 15 days after the second dose (Vaxzevria). Both brands: Thrombosis and thrombocytopenia (some cases with bleeding), rarely observed post-vaccination, including severe cases presenting as venous thrombosis, (including unusual sites e.g. cerebral venous sinus thrombosis, splanchnic vein thrombosis) and arterial thrombosis, with thrombocytopenia (some cases fatal). Majority occurred within the first 3 weeks post-vaccination, mostly in women under age 60 years. Healthcare professionals to be alert to signs and symptoms of thromboembolism and/or thrombocytopenia and instruct those vaccinated to seek immediate medical attention if post-vaccination they develop symptoms after a few days e.g. shortness of breath, chest pain, leg swelling, leg pain, persistent abdominal pain OR neurological symptoms e.g. severe or persistent headaches, blurred vision, confusion or seizures OR skin bruising (petechia) beyond the vaccination site. Immune thrombocytopenia (ITP), an autoimmune condition with low blood platelet levels). Guillain-Barré syndrome (GBS) (very rare) reported following vaccination. Healthcare professionals to be alert for GBS signs and symptoms; ensure correct diagnosis (or rule out other causes) and initiate adequate supportive care and treatment.  Anxiety-related reactions, concurrent illness, thrombocytopenia, coagulation disorders, see Class Effects above. ​
Janssen: Capillary leak syndrome (CLS) (very rare) reported in the first days after vaccination, some cases fatal. CLS characterised by acute episodes of oedema (mainly limbs), hypotension, haemoconcentration, hypoalbuminaemia. Acute CLS episode following vaccination requires prompt recognition, treatment. Intensive supportive therapy is usually needed. Do not vaccinate with known CLS history. 
Venous thromboembolism. Dizziness and tinnitus. Swollen lymph nodes, unusual or decreased feeling in the skin, tinnitus, diarrhoea and vomiting. Transverse myelitis (inflammation in parts of the spinal cord).
Vaxzevria: Pain in legs and arms or stomach and influenza-like symptoms.
  • ADRs: Summary, most frequent: Both brands, injection site pain, headache, fatigue, myalgia, pyrexia, nausea. Reactogenicity was generally milder and reported less frequently in older adults (age 65 years and older). Janssen: Most adverse reactions occurred within 1-2 days post-vaccination and were mild to moderate in severity and of short duration (1-2 days). Vaxzevria: Injection site tenderness, malaise, chills, arthralgia. Most adverse reactions were mild to moderate in severity and usually resolved within a few days post-vaccination. Compared with Dose 1, adverse reactions reported after Dose 2 were milder and reported less frequently.
▼ COVID-19 Vaccine Janssen (Janssen-Cilag/Johnson & Johnson)
Injection, COVID-19 rDNA 0.5mL (one dose). Recombinant DNA technology. Adenovirus type 26 encoding SARS-CoV-2 Spike (S) glycoprotein (Ad26.COV2-S). Colourless (slightly-yellow) clear (very-opalescent). 
Excipient(s): Essentially sodium-free; ethanol 2mg/0.5mL. 
Store, Transport: Freeze (-25 to -15 deg). Can be refrigerated (2-8 deg C) for single period of up to 3 months. Do not re-freeze. Vials in outer carton (light). In-Use (not for storage or transport): Unopened, 9-25 deg C; max. 12  hours. 
[Information up-to-date (EMA): October 2021]
 
▼ Vaxzevria COVID-19 Vaccine (AstraZeneca)
Injection, COVID-19 rDNA 0.5mL (one dose). Recombinant DNA technology. Chimpanzee Adenovirus encoding SARS-CoV-2 Spike (S) glycoprotein (ChAdOx1-S). Colourless (slightly-brown) clear (slightly-opaque). 
Excipient(s): Essentially sodium-free; ethanol 2mg/0.5mL. 
Store: Refrigerate (2-8 deg C). Do not freeze. Vials in outer carton (light). 
[Information up-to-date (EMA): October 2021]
 
Page updated: 17 November 2021